FDA overhauls COVID vax approval process to focus on older populations, high-risk individuals

The Food and Drug Administration is shifting its annual COVID-19 vaccine approval policies to focus on Americans older than age 65 and other “high-risk” individuals, while increasing the standard of evidence to approve COVID vaccines for low-risk individuals. 

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” FDA’s Center for Biologics Evaluation and Research chief, Vinay Prasad, and FDA Commissioner Martin Makary, wrote in the New England Journal of Medicine Tuesday. “These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.” 

Americans over the age of 65 and those considered at high-risk of contracting the virus will be able to receive an annual COVID-19 vaccine this fall, the essay outlined, while vaccines for low-risk Americans will likely face stricter scientific analysis before they are made available to the public. The FDA estimated that about “100 million to 200 million Americans” older than age 65 or considered at high-risk will still have access to vaccines. 

Prasad and Makary said in their essay that the U.S. will move away from a “one-size-fits-all” paradigm that promoted COVID-19 vaccines for the vast majority of Americans, stretching from children to the elderly. The shift, they said, will bring America’s policies more in line with guidelines in European nations. 

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“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” the health leaders wrote in the New England Journal. 

“The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,” they wrote. “We reject this view.” 

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The FDA’s policy shift will include requiring vaccine manufacturers to gather clinical trial data to justify rolling out new COVID-19 vaccines for Americans at low risk of contracting the virus. 

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Prasad and Makary held a roundtable discussion on the framework outlined in their medical essay Tuesday afternoon to walk Americans through the policy shift. Prasad explained that health officials under the Trump administration are taking into account that Americans have balked at the FDA’s guidance under the Biden administration to receive multiple booster shots, while other Americans demand access to the vaccines. 

“We have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID 19 vaccine doses or boosters,” he said. “There are some Americans out there who are worried that the FDA has not fully documented and interrogated the safety harms of these products, and they are categorically opposed to these products. There are also some Americans we also have to recognize, who are desperate for additional protection, and they demand these products. But the truth is that most doctors and most of the public are entirely uncertain, and that is reflected in low vaccine uptake of these products.” 

The pair added during the roundtable that Americans’ trust in the scientific community has cratered since the pandemic. 

“Survey after survey shows trust in institutions like the FDA and scientists in general, it’s rock bottom,” Prasad said during the roundtable. “I mean, we have lower trust than Congress, and that’s saying something, you know. And we need to rebuild that trust. And part of rebuilding that trust is having conversations like this, writing articles like we’ve done in the New England Journal, and having a common-sense evidence-based framework for rebuilding that trust.” 

The pair cited in their article in the New England Journal that “public trust in vaccination in general has declined,” including for “vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective.”